Sepsis - A Serious and Growing Threat to Patient Safety

Sepsis (Greek, meaning putrefaction or decay) is a potentially life-threatening complication from a serious infection. It is the leading cause of morbidity and mortality worldwide.1 It is the leading cause of death in non-coronary intensive care units, and the 10th leading cause of death in the United States overall. Mortality rates for severe sepsis and septic shock have been reported at between 20-30%, depending in large part on how quickly patients are diagnosed and treated.

Delays in the diagnosis and treatment of sepsis, and failure to adequately treat the condition, may give rise to medical negligence claims.

What is sepsis?

Sepsis is defined as the presence of infection, together with a systemic inflammatory response to the infection.2 Severe sepsis is sepsis that leads to organ dysfunction. And septic shock is severe sepsis plus hypotension that does not respond to adequate fluid resuscitation.3 Anyone can develop sepsis, but specific categories of people are at an increased risk, including:

patients diagnosed with bacteremia (blood-borne infection);

people over the age of 65;

immunosuppressed patients;

diabetics;

cancer patients;

patients with community acquired pneumonia; and

people genetically predisposed to infection.4

Any infection can cause sepsis to occur, with the most common infection sites being in the urinary tract, gastrointestinal tract, respiratory tract, and skin.

Diagnosis

Timely diagnosis of sepsis requires a high index of suspicion, because signs and symptoms of the disease can be subtle and attributable to other disorders. Patients may have a fever, chills, elevated heart rate, or elevated respiratory rate. Further, there may not be an obvious source of the underlying infection.

Vigilant primary care providers should include sepsis on their differential diagnosis when faced with a patient who has a likely infection and who seems more sick than expected. It is important to rule in or rule out sepsis quickly. This workup will include lab work, a detailed history, a physical exam, and possibly imaging.

Treatment

It is important to both treat the patient’s symptoms and find and address the source of the infection.5

Early management of patients with severe sepsis or septic shock includes stabilizing the airway and breathing, followed by restoring blood flow to the peripheral tissues and starting appropriate antibiotics.6 Because patients typically have both hypotension (abnormally low blood pressure) AND hypovolemia (abnormally low blood volume), it’s also important to rapidly resuscitate the patient’s fluid volumes. For patients who do not respond adequately with fluid resuscitation alone, vasopressors are indicated. These act as vasoconstrictors – they constrict blood vessels and thus elevate the mean arterial pressure.

Although these measures are vital for the patient, finding and treating the source of the infection are also critical steps in the management of sepsis. Certain infections may be treated relatively easily, including those that are amenable to drainage (e.g. abscess). However, surgery may be needed to remove other sources.

Prognosis

Prognosis hinges on a number of factors, including the patient’s response to infection, the site and type of infection, and the timing of antimicrobial therapy.7 In addition, the patient’s baseline level of health often affects the outcome: if the patient has co-morbidities, is elderly, or otherwise is less able to fight infection, the prognosis is worse. The harms of sepsis can be catastrophic, particularly when the disease is allowed to progress to severe sepsis and septic shock. Mortality rates range from 10 to 52 percent, and increase as sepsis develops.8

Short of death, sepsis can lead to extended hospital stays and various complications. These include organ failure, Disseminated Intravascular Coagulation (DIC: a systemic process involving the abnormal formation of clots in the blood vessels), purpura fulminans (a thrombotic disorder resulting from coagulation in small blood vessels, often associated with a severe infection), and the loss of limbs.9,10

Tissue death resulting in the loss of all or parts of limbs can occur for a number of reasons. First, sepsis causes a dramatic drop in blood pressure. For that reason, doctors must administer vasopresssers to restrict blood flow to the extremities in order to shunt more blood flow to the patient’s vital organs.

Second, when the bacteria causing the sepsis are killed, they release toxins, which in turn can damage the lining of the blood vessels. This causes a condition that forms clots, mainly in the smaller arteries leading to the hands and feet. The worse the sepsis, the more bacteria must be killed, the more toxins are produced, and the more clotting that occurs. The clotting that occurs then restricts blood flow to the hands and feet even more.

Together, the reduction in blood flow due to the need for pressors and the blockages from clotting in the arteries starve the muscles and other tissues in the hands and feet, much as if tourniquets had been placed around those extremities. It is an unfortunate reality that sepsis treatment required to save the patient’s life can contribute to loss of limb tissue, even resulting in amputations of feet and/and hands.

Medical/Legal Issues

As noted above, the key to successful treatment of sepsis is early diagnosis and treatment.

Negligence Areas to Investigate

A case may involve a patient who presents with signs and symptoms of an infection that are unrecognized, allowing the infection and its complications to progress to severe sepsis and septic shock. This type of case may involve an initial analysis of the following:

What history did the physician take from the patient? Did the doctor learn about the patient’s baseline level of health? For example, a patient may not have a fever despite an infection, but it is suppressed because they are otherwise immunocompromised (diabetic, for example, or taking steroids). Did the doctor ask the patient appropriate questions that may uncover the source of the infection causing the symptoms? For example, without learning from the patient that she was recently treated for kidney stones or worked up for urinary tract infections (UTI), the doctor may not order the appropriate tests to discover that the infection is being caused by a kidney stone.

What clinical signs and symptoms did the patient present with? In early stages, symptoms of sepsis may be vague and attributable to other problems, but a reasonably prudent provider will consider sepsis on his or her differential when faced with the appropriate symptoms. Does the patient have a fever or hypothermia? Is the patient’s heart rate high? Is the patient breathing rapidly? Is the patient’s blood pressure low?

What tests were ordered? Did the physician have vital signs taken? Was a baseline (heart rate, respiratory rate, blood pressure) established? Were appropriate laboratory tests ordered and performed in a timely manner?

At this point, sepsis may not yet be on the doctor’s differential diagnosis list. If it is not, should it be? If it is reasonable for sepsis to not be on the doctor’s list, what further workup did the doctor do to investigate the cause of symptoms? Were additional tests ordered (including possibly imaging studies) to find the source of the infection, or additional lab work to investigate? Did the doctor consider that the patient was particularly predisposed to sepsis? Did she have co-morbidities? Diabetes? Chronic steroid use?

If the diagnosis of sepsis is made or at least considered, it is possible to have a claim for improperly treating sepsis, including failing to adequately treat the underlying infection and/or failure to seek consults from other specialties?

Did the doctor aggressively respond to the diagnosis? One guideline for treating sepsis is “Surviving Sepsis Campaign; Inter­na­tional Guidelines for Management of Severe Sepsis and Septic Shock: 2012.” It details the steps to take, depending on the severity of the disease at the time of diagnosis, and includes immediate antibiotics, IV fluids, pressors, and appropriate monitoring.

Importantly, it is crucial to find and treat the underlying infection. When an abscess is continuing to infect the bloodstream, for example, it must be drained as soon as possible. If a foreign body is causing the infection, it must be identified and removed quickly. If a kidney stone is blocking urine from draining from the kidney, adequate drainage must be reestablished as fast as reasonably possible. Failing to take these necessary steps quickly can result in a much worse outcome for the patient and give rise to provider liability.

Along with failing to timely diagnose treat sepsis (including its infection source), provider liability can be established through communication errors between providers. Often patient care is divided among doctors, nurses, consulting specialists, and laboratory workers, and communication errors between these people can result in patient harm. Are proper instructions being given from outgoing to incoming providers? Are nurses properly reporting changes in a patient’s status to the doctor? Is there a system in place to properly and timely communicate abnormal and critical lab values?

Defense negligence themes

Although many of the below defense themes are found generally in medical malpractice cases, it is useful to discuss them in the context of a case involving sepsis.

Doctors acted appropriately:

Sepsis, severe sepsis and septic shock can be difficult to diagnose, and it is up to the provider to use his or her clinical judgment at the time of treating the patient. Unfortunately, there is no established consensus for how to diagnose or treat this disease, in part because it can manifest itself in many different ways. In addition, medications patients are on could be masking the signs of inflammatory response.

It is reasonable to assume that initial test abnormalities are due to a benign reason. Lab results are often equivocal, and oftentimes so-called “abnormal” results can reasonably be explained by other, more likely causes at the time of the interpretation.

Finally, when a septic patient is critically ill, physicians are faced with attempting to save a life. Unfortunately bad outcomes short of death occur, and providers can be seen as heroes for saving the patient’s life, even if their negligent care may have caused the deadly situation.

Different care would not have changed the ultimate outcome:

During the course of the sepsis, it is often impossible to say whether earlier intervention would have prevented the ultimate outcome. With respect to sepsis cases particularly, the defense may argue that once bacteria is in the blood stream, there is a cascade of physiological responses set in motion that may not be altered by even the best care. Further, patients may have mottled and pale skin or extremities that, at the time, can reasonably be explained by an underlying condition (e.g., diabetes). However, upon reflection, those were signs that blood flow had already been impaired to those extremities to the extent that intervention at that time would not have changed the ultimate outcome.

When sepsis is included in the differential or even diagnosed, time can be of the essence. Delays of even a few hours can reduce the chance for a good outcome. Many patients are initially diagnosed in the ER or upon admission to a hospitalist service. It may be crucial for those doctors to seek urgent consults with infectious disease experts, critical care specialists, or others who may be able to treat the underlying infectious source.

Patient fault:

As anyone who handles medical malpractice cases knows, the defense will often either overtly state or otherwise imply that the patient herself is responsible for the delay in diagnosing her condition. In particular, the patient is often counseled at discharge to return if symptoms do not get better or worsen. It is up to the patient to follow these instructions. Further, patients may not always be the most accurate reporters, particularly with regard to co-morbidities and current medications, including steroids.

Case Examples

A young mother presented to a rural hospital ER with symptoms of pneumonia, verified by a chest x-ray. She was given medications and sent home. Later that day, her condition worsened and she returned to the ER where an initial diagnosis of sepsis was made and she was transported by ambulance to a nearby hospital with better treatment facilities. She died from septic shock during the ambulance trip. The patient was diabetic and an alcoholic.

An elderly man with serious chronic illnesses was hospitalized with abdominal pain. He then began to develop signs of sepsis and it was found on CT that he had a ruptured appendix. A decision had to be made whether to surgically treat the appendix rupture or attempt non-surgical treatment. Because of his co-morbidities, it was felt that surgery was too risky. He died the next day from complications of sepsis.

A woman in her fifties presented to an ER with signs and symptoms of a blocked kidney stone. Because of the small size of the stone, she was given pain and anti-nausea medications and sent home with the hope she would pass the stone. The next day her condition worsened and she returned to the ER. Upon admission to the hospital, a diagnosis of sepsis was made. While the hospitalist was obtaining infectious disease and urology consults, the patient was treated aggressively with fluids and pressors. By the time the source of the infection was surgically treated, however, she had lost viable tissue in both her hands and feet and underwent quadruple amputations.

A young mother who was pregnant developed a pneumococcal infection in the last part of her pregnancy. By the time she was seen by her obstetrician, she was seriously septic. Fortunately, they were able to do a cesarian-section birth and the child is fine. But the mother ended up losing both legs and one hand, and is blind, as a result of the sepsis damages.

Conclusion

Sepsis, severe sepsis, and septic shock can kill or maim, even with appropriate care, depending on the circumstances. Still, liability can be established in cases where health care providers had sufficient chance to find and treat the source of the infection while simultaneously addressing the patient’s symptoms, and failed to do so.

Because the damages are often catastrophic, an adequate evaluation of a potential case can mean consultations with many medical specialties, such as primary care physicians, hospitalists, infectious disease specialists, and critical care specialists. A good starting point for an attorney evaluating a potential sepsis case is review by a critical care specialist, because in most cases a patient will end up being seen by that specialty. A good source for potential experts is the group of physicians who wrote the guidelines for the “Surviving Sepsis Campaign.”